NCT00276965

Bipolar II Depression: Lithium, SSRI, or the Combination

Comparing the Safety and Effectiveness of a Mood Stabilizing Medication, an Antidepressant Medication, and a Combination of Both Medications to Treat Symptoms of Bipolar Type II Depression

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 139 (actual)
• Sponsor: Lindner Center of HOPE · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study will compare the safety and effectiveness of a mood stabilizing medication, an antidepressant medication, and a combination of both medications to treat symptoms of bipolar type II depression.

Detailed description

Bipolar type II depression (BD II) is a less severe type of bipolar disorder. BD II is characterized by one or more depressive episodes and at least one hypomanic episode. During hypomanic episodes, people experience especially energetic or anxious moods, and their thoughts are more sporadic than usual, but they do not experience the severity of mania. Symptoms of BD II are known to impair daily functioning as well as cause distress and even suicide. Antidepressant medication alone is not recommended for people with bipolar disorder because manic symptoms usually worsen. It is unknown whether the same recommendation should apply to people with BD II. Sertraline is a selective serotonin reuptake inhibitor (SSRI) antidepressant that increases levels of serotonin, helping the brain to maintain mental stability. It is often used to treat depression, panic attacks, and other disorders. Lithium is a mood stabilizing medication that decreases abnormal brain activity and is used to treat and prevent recurring episodes of mania in people with bipolar disorders. This study will evaluate the effectiveness of lithium alone, sertraline alone, and lithium with sertraline to treat symptoms of BD II. Participation in this double-blind study will last up to 18 weeks. Participants will be randomly assigned to receive either lithium, sertraline, or lithium and sertraline. Both medications will initially be given at a low dose and then gradually increased over 2 weeks. For the remainder of the study, dosages will be adjusted as necessary. Study visits will occur every week for the first 6 weeks and then every other week for the remaining 10 weeks. During all study visits, participants will complete a psychiatric assessment and questionnaires about their current mood and any treatment side effects. Urine and blood collection may occur at selected times during the study.

Conditions

• Bipolar Disorder
• Depression

Interventions

Type	Name	Description
DRUG	Sertraline	Sertraline or placebo for sertraline starting at 25 mg per day, up to maximum of 200 mg per day
DRUG	Lithium carbonate	Lithium or placebo for lithium starting at 150 mg per day; target dose of 900mg per day. Maximum dose based on clinical response and serum levels (maximum serum level of 1.2 mEq/L).

Timeline

• Start date: 2006-09-01
• Primary completion: 2012-03-01
• Completion: 2012-07-01
• First posted: 2006-01-13
• Last updated: 2013-05-10

Locations

3 sites across 1 country: United States